RECRUITING

Defining the Basis of Fibromuscular Dysplasia (FMD)

Conditions

Fibromuscular Dysplasia Spontaneous Coronary Artery Dissection Cervical Artery Dissection Cross-sectional study Fibroblast

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study has evolved and expanded since its inception. Originally the intent was to establish the functional, molecular and genetic profile of fibroblasts from Fibromuscular Dysplasia (FMD) patients as compared to carefully matched control subjects. While this remains among the objectives, the study has been expanded to undertake a fully powered cross-tissue systems genetics analysis of FMD, and now also the related arteriopathies spontaneous coronary artery dissection (SCAD) and cervical artery dissection (CvAD). The overall objective is to disclose the core biologic mechanisms of these disorders.

Official Title

Defining the Basis of Fibromuscular Dysplasia: The Define-FMD Study

Quick Facts

Study Start:2013-10

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01967511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients of any age and freely willing to participate. For patients \< 18 years of age consent will be via parents. * Fluency in either English or Spanish. * Signed, informed consent * For FMD, SCAD or CvAD subjects - a clinical diagnosis of FMD, SCAD or CvAD with fulfillment of standard diagnostic criteria. * For healthy controls - no clinical features of FMD, SCAD or CvAD and absence of any major ongoing systemic disease including any condition requiring hospitalization, immune suppression, intravenous or injected medications or that result in functional impairment in the performance of activities of daily living. Healthy controls will be matched to enrolled FMD patients on the basis of gender and approximate age (within a 5 year window of another FMD subject).	* Patients who have co-morbidities which reduces life expectancy to one year. * Patients with any solid organ or hematological transplantation, or those in whom transplantation is considered. * Active autoimmune disease. * Illicit drug use. * HIV positive. * Prior malignancy. * Any other form of vascular disease, including other arteriopathy coronary artery disease or peripheral vascular disease * Family history of arteriopathy other than FMD, SCAD or CvAD (e.g. Ehlers-Danlos syndrome)

Inclusion Criteria

Exclusion Criteria

* Patients of any age and freely willing to participate. For patients \< 18 years of age consent will be via parents.
* Fluency in either English or Spanish.
* Signed, informed consent
* For FMD, SCAD or CvAD subjects - a clinical diagnosis of FMD, SCAD or CvAD with fulfillment of standard diagnostic criteria.
* For healthy controls - no clinical features of FMD, SCAD or CvAD and absence of any major ongoing systemic disease including any condition requiring hospitalization, immune suppression, intravenous or injected medications or that result in functional impairment in the performance of activities of daily living. Healthy controls will be matched to enrolled FMD patients on the basis of gender and approximate age (within a 5 year window of another FMD subject).

* Patients who have co-morbidities which reduces life expectancy to one year.
* Patients with any solid organ or hematological transplantation, or those in whom transplantation is considered.
* Active autoimmune disease.
* Illicit drug use.
* HIV positive.
* Prior malignancy.
* Any other form of vascular disease, including other arteriopathy coronary artery disease or peripheral vascular disease
* Family history of arteriopathy other than FMD, SCAD or CvAD (e.g. Ehlers-Danlos syndrome)

Contacts and Locations

Study Contact

Jason Kovacic, MD, PhD

CONTACT

212-241-7014

jason.kovacic@mountsinai.org

Jeffrey Olin, DO

CONTACT

jeffrey.olin@mountsinai.org

Principal Investigator

Jason Kovacic, MD, PhD

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Jeffrey Olin, DO

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

Jason Kovacic, MD, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
Jeffrey Olin, DO, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-10

Study Completion Date2025-12

Study Record Updates

Study Start Date2013-10

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Cross-sectional study
Fibromuscular dysplasia
Fibroblast
Spontaneous Coronary Artery Dissection
Cervical Artery Dissection

Additional Relevant MeSH Terms

Fibromuscular Dysplasia
Spontaneous Coronary Artery Dissection
Cervical Artery Dissection